Spectrum Regulatory Solutions

Device regulation updates and proposals

Spectrum Regulatory Solutions — Wed, 24 Apr 2013 15:09:50 +0000

April 2013: The EU Committee on the Environment, Public Health and Food Safety has issued a draft report “On the proposal for a regulation of the European Parliament and the Council on medical devices” which calls for a new authorisation procedure requiring premarket approval prior to sale. In addition, the International Medical Device Regulators’ Forum (IDRF) has released a Non-IVD Market Authorization Table of Contents, intended to support a smooth documentation process for any regulatory submissions. Both of these set to make devices regulation more similar to that for pharmaceuticals.

New Declaration of Helsinki proposed

Spectrum Regulatory Solutions — Wed, 24 Apr 2013 15:03:47 +0000

April 2013: The World Medical Association has proposed altered wording for the Declaration of Helsinki, and released the revised document for public consultation. The new version aims to provide greater protection for vulnerable groups in general, includes a clause regarding compensation, has more detailed requirements for post-study arrangements, a more systematic approach to the use of placebos, and has been restructured in order to aid readability. The document has not increased in length, nor have its core aims changed. The consultation will close on 15^th June 2013.

Change to UK patent laws to benefit clinical research

Spectrum Regulatory Solutions — Thu, 18 Apr 2013 13:31:58 +0000

March 2013: The UK government announced on 26^th February that in response to the Intellectual Property Office consultation, the law will be changed in order for clinical trials to be performed without the risk of patent infringement. Both the Minister for Universities and Science, and the Minister for Intellectual Property have stated that they feel this will create an environment conducive to pharmaceutical research. The use of patented drugs as a comparator in clinical trials for market authorisations will no-longer be a patent infringement.

FDA releases Q&A on non-clinical ICH guideline

Spectrum Regulatory Solutions — Thu, 18 Apr 2013 13:31:10 +0000

March 2013: The FDA has released a Q&A document for comment entitled “M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions and Answers(R2)”. Since the M3(R2) guidance is complex with a broad scope and is significantly different from the M3(R1) guidance, the FDA felt the Q&A document would be useful in order to clarify key issues. The document incorporates changes approved in December 2011 and March 2012.

Revision of EMA guidance documents to include orphan information

Spectrum Regulatory Solutions — Thu, 18 Apr 2013 13:30:14 +0000

March 2013: The EMA has updated guidance documents relating to the centralised procedure pre-authorisation, post-authorisation and generic/hybrid products to include information pertaining to orphan medicines. Q&A sections are included for orphan products.

Standard Paediatric Investigation Plans for oncology products

Spectrum Regulatory Solutions — Thu, 18 Apr 2013 13:28:59 +0000

March 2013: The EMA has released standard Paediatric Investigation Plans (PIPs) for acute myeloid leukaemia and rhabdomyosarcoma. The documents identify priority patient subsets and key binding elements for the diseases to encourage development of a PIP. Adhering to the principles of a standard PIP may facilitate the approval process.

China to reform regulatory processes

Spectrum Regulatory Solutions — Thu, 18 Apr 2013 13:26:25 +0000

March 2013: In order to promote the healthy development of China’s pharmaceutical industry, the State Food and Drug Administration has announced that it intends to implement four areas of reform. They intend to have independent intellectual property rights and expedited drug review process, a revised national strategy for generic drugs, strengthen the quality and management of clinical trials including the use of an independent ethics committee, and also to encourage the development of drugs for children.

ABPI to help industry with data transparency

Spectrum Regulatory Solutions — Thu, 18 Apr 2013 13:25:29 +0000

March 2013: The Association of the British Pharmaceutical Industry (ABPI) has announced measures intended to help industry comply with the data transparency clauses in its Code of Practice, and also to ensure that they are being met. An independent third party provider will be appointed to ensure compliance, and breaches will be reported to the Prescription Medicines Code of Practice Authority. In addition, a number of tools will be available to encourage greater compliance, including checklists and standard SOP templates, and also workshops hosted by the ABPI.

Spectrum obtains SME status as a micro autonomous consultancy with the EMA

Spectrum Regulatory Solutions — Fri, 15 Feb 2013 16:08:09 +0000

February 2013: Spectrum is now registered with the European Medicines Agency (EMA) as a micro autonomous regulatory consultancy. This means that we are eligible to apply for a range of incentives from the EMA. These include administrative and procedural assistance, fee reductions of up to 90% for scientific advice and scientific services, and fee exemptions for certain EMA administrative services.

GVP Module XV comes into force

Spectrum Regulatory Solutions — Thu, 14 Feb 2013 12:08:15 +0000

February 2013: Module XV of the Guideline on good pharmacovigilance practices came into effect on 24^th January 2013. The module relates to safety communication, and provides guidance to sponsors, competent authorities and the EMA on how to communicate and co-ordinate safety information in the EU.